Zachary Brennan
Senior Editor
The clinical trial ecosystem in North America was upended quickly by Covid-19, casting a giant spotlight on inefficiencies and the need to make room for more decentralized clinical trials.
And Canada is prepared to do just that, revealing in a summary on Wednesday in its proposal to modernize its clinical trial system that enabling more of these decentralized trials — centered on patients rather than a single or multiple trial sites — “is an important initiative, as over 30% of the population lives outside medium-sized and large urban areas.”
Some industry respondents said they favored a hybrid approach for decentralized trials, according to Health Canada, meaning “a combination of site and virtual/remote options. Some assessments could be remote (performed at the patient’s home or in their local care community). Or there could be a mix of partial-remote/partial-traditional (performed on-site) within the same study.”
Such an approach would increase participants’ options, which could mean a greater proportion of the population could participate in trials. But the way that such a system is set up will need to be specific on what can and cannot occur off-site.
“I do have some concerns, mainly related to the integrity and the validity of the data collection,” Mary McDermott, a professor of medicine at Northwestern University, who treats and studies vascular diseases that can make it hard for older people to walk easily, told PNAS in a November article on decentralized trials.
The need for better harmonization with the US FDA was also one of the top suggestions for improving the trial framework in Canada.
Janet Woodcock, who recently shifted to principal deputy commissioner at the FDA and previously served as the therapeutics lead at Operation Warp Speed, has signaled the need for ways to address what she saw as Covid-19 clinical trial inefficiencies and a dearth of community-based research infrastructure.
Last February, Woodcock published an article in Nature Reviews Drug Discovery in which she explained how just 5% of the almost 3,000 Covid-19 therapeutic trials were actually randomized and adequately powered to reveal actionable data.
“There was a tremendous amount of duplication, and a lot of small trials that yielded tantalizing information that sent people off to use treatments that were not useful and potentially harmful,” Woodcock said at an event last year. “In a global emergency we need to have more central coordination because we should really randomize the first patient.”
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Given Rob Califf’s extensive experience and knowledge of the clinical trials landscape, this might be one key early priority.
In his first run as FDA commissioner under President Obama, Califf was involved in cross-FDA modernization of the system by which the FDA collects evidence. He’s also been a vocal proponent of real-world data with randomization.
“We worried at the time that the terms RWD & RWE [real-world evidence] would be hijacked to foster low quality research. This must be fought, because well done RWD & RWE with proper use of methods for causal inference is HIGHER quality & more generalizable,” Califf wrote in 2020.
Still, the use of full or hybrid decentralized designs by trial sponsors has been rare in oncology, the FDA noted in a recent guidance from last year, partly because of the uncertainty surrounding the effect of remote assessments on data quality and outcomes.
But the FDA insists that better understanding certain remote modifications can reduce uncertainty for sponsors and regulators, and identify mitigation strategies for future, prospective decentralized designs.
The agency is calling for companies to flag any instances of remotely conducted clinic visits, lab or imaging assessments, or delivery of investigational products.
Source: https://endpts.com/canada-wants-to-clear-the-way-for-more-decentralized-clinical-trials-will-the-us-follow-suit/